POS1053 LONG-TERM RETENTION, EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: RESULTS FROM THE OBSERVATIONAL SERENA STUDY
Authors: U. Kiltz, P. Sfikakis, N. Gullick, P. Katsimpri, A. Kotrotsios, J. Brandt-Juergens, E. Lespessailles, N. Maiden, K. Gaffney, D. Peterlik, B. Schulz, E. Pournara, P. Jagiello
Journal: Annals of the Rheumatic Diseases (2022)

Background SERENA is an ongoing, longitudinal, observational study of more than 2900 patients (pts) with moderate to severe psoriasis, active psoriatic arthritis (PsA), and ankylosing spondylitis (AS) conducted at 438 sites across Europe with an expected duration of up to 5 years. 1,2 Objectives We report long-term results (at least 3 years follow up) on secukinumab (SEC) retention, effectiveness and safety in pts with active PsA or AS from the SERENA study. Methods This analysis includes data of 524 PsA and 473 AS pts enrolled in the study and followed up for at least 3 years. Pts (aged ≥18 years) with active PsA or AS were required to have received at least 16 weeks of SEC treatment before enrolment in the study. Retention rate was defined as the percentage of pts who have not discontinued SEC treatment. Effectiveness assessments included swollen and tender joint counts (SJC and TJC) in pts with PsA, and BASDAI score in pts with AS. Safety assessments included the number of pts with any adverse events (AEs) and serious AEs, treatment-emergent AEs, AEs of special interest and their incidence rates. Results The mean (SD) treatment duration prior to enrolment in the study for PsA and AS pts was 1.0 (0.5) years and 0.9 (0.5) years, while time since diagnosis was 8.7 (7.4) and 9.8 (9.5) years, respectively. Prior to SEC initiation, 67.4% of pts with PsA and 63.0% of pts with AS received a biologic therapy, with lack of efficacy reported as major reason for discontinuation (PsA: 89.5%; AS: 87.6%). SEC retention rates after at least 3 years since enrolment in the study were 67.3% for pts with PsA and 72.1% for pts with AS. Survival probabilities for individual indications are presented in Figure 1. Over 3 years of observation, SEC showed sustained effectiveness in pts with PsA [SJC, mean (SD): baseline, 3.2 (5.6); Year 3, 1.7 (2.7) and TJC: baseline, 6.4 (9.4); Year 3, 4.9 (6.4)] and AS [BASDAI, mean (SD): baseline, 3.2 (2.3); Year 3, 2.7 (2.2)]. No new or unexpected safety signals were reported; 11.0% of pts with PsA (N=574) and 12.9% of pts with AS (N=505) reported serious AEs (Table 1). Table 1. Overall safety profile within the study period (Safety set ) Variable, n (%) unless otherwise specified PsA (N=574 ) AS (N=505 ) Pts with AE (≥1 ) 327 (57.0) 291 (57.6) Pts with SAE (≥1 ) 63 (11.0) 65 (12.9) AE leading to death 3 (0.5) 3 (0.6) AE leading to discontinuation 119 (20.7) 81 (16.0) Treatment emergent AE leading to discontinuation (in &gt; 1% pts in any group ) n (% ) IR n (% ) IR General disorders and administration site conditions 74 (12.9) 4.90 50 (9.9) 3.75 Skin and subcutaneous tissue disorders 13 (2.3) 0.86 3 (0.6) 0.22 Musculoskeletal and connective tissue disorders 26 (4.5) 1.72 9 (1.8) 0.67 Infections and infestations 2 (0.3) 0.13 7 (1.4) 0.52 Gastrointestinal disorders 2 (0.3) 0.13 3 (0.6) 0.22 Neoplasms benign, malignant and unspecified (incl cysts and polyps) 4 (0.7) 0.26 3 (0.6) 0.22 Injury, poisoning and procedural complications 0 0 2 (0.4) 0.15 Treatment emergent AE of special interest (PT ) n (% ) IR n (% ) IR Candida infections 2 (0.3) 0.13 4 (0.8) 0.30 Malignancy 8 (1.4) 0.53 5 (1.0) 0.37 MACE 3 (0.5) 0.20 4 (0.8) 0.30 Injection site reaction 0 0 2 (0.4) 0.15 Inflammatory bowel disease 1 (0.2) 0.07 2 (0.4) 0.15 Safety set consisted of pts who received at least one dose of SEC treatment after signing the informed consent AE, adverse event; AS, ankylosing spondylitis; IR, incidence rate; MACE, major adverse cardiac events; N, total number of pts; n, number of pts; PsA, psoriatic arthritis; pts, patients; PT, preferred term; SAE, serious adverse event; SEC, secukinumab Conclusion After more than 3 years of observation in the SERENA study, SEC showed sustained retention rates, indicating high persistence in a real-world setting. Responses across effectiveness assessments in both PsA and AS cohorts were maintained or improved during the 3 years of follow up in the study. SEC showed a favourable safety profile, consistent with previous reports. References [1]Kiltz, U et al. Adv Ther 2020;37:2865–83 [2]Kiltz, U et al. Ann Rheum Dis 2021;80:337–38 Disclosure of Interests Uta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Petros Sfikakis Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Nicola Gullick Speakers bureau: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, Consultant of: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, Grant/research support from: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, PELAGIA KATSIMPRI Speakers bureau: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Consultant of: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Grant/research support from: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Anastassios Kotrotsios: None declared, Jan Brandt-Juergens Speakers bureau: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Consultant of: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Eric Lespessailles Speakers bureau: Amgen, Expanscience, Lilly and MSD, and research grants from Abbvie, Amgen, Lilly, MSD and UCB, Consultant of: Amgen, Expanscience, Lilly and MSD, and research grants from Abbvie, Amgen, Lilly, MSD and UCB, Nicola Maiden Consultant of: Eli-Lilly and UCB, Karl Gaffney Speakers bureau: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Consultant of: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Grant/research support from: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Daniel Peterlik Employee of: Novartis, Barbara Schulz Employee of: Novartis, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Piotr Jagiello Employee of: Novartis